MODELO DE BULA (COMPLETA)
®
AVICIS
alfaestradiol 0,025%
Solução Capilar

FORMA FARMACÊUTICA, VIA DE ADMINISTRAÇÃO E APRESENTAÇÃO

Solução para uso tópico no couro cabeludo. Embalagens com 1 frasco plástico de 100ml,
acompanhado de aplicador.
USO ADULTO
COMPOSIÇÃO
Cada ml do produto contém:
Alfaestradiol………………………………………………………………………………. 0,25 mg
Veículo………………………………………………………………………… q.s.p…….. 1 ml
Veículo constituído de inositol, glicerol, álcool isopropílico e água purificada.

INFORMAÇÕES AO PACIENTE
Leia cuidadosamente antes de iniciar o tratamento e a cada vez que você comprar o produto, pois
podem haver informações novas. Consulte o seu médico se você tiver outras dúvidas sobre a doença
ou sobre este produto.

Como este medicamento funciona?
AVICIS é um medicamento para uso externo e contém alfaestradiol, como substância ativa. AVICIS
não apresenta efeitos hormonais e atua no couro cabeludo sobre os fatores responsáveis pelo
desenvolvimento da calvície. A melhora na queda dos cabelos não deve ser esperada antes de pelo
menos 1 mês de tratamento.

Por que este medicamento foi indicado ?
AVICIS é indicado para o tratamento da alopecia androgenética, queda dos cabelos causada por
fatores hormonais, que ocorre geralmente a partir dos 30 anos de idade. AVICIS pode ser utilizado em
homens e mulheres.


Quando não devo usar este medicamento ?

Contra-indicações: AVICIS não deve ser usado se você tiver alergia às substâncias da fórmula.
Advertências e Precauções:
O produto deve ser usado exclusivamente para aplicação tópica no couro cabeludo, não deve ser
aplicado em outras áreas do corpo. Evite o contato com os olhos e mucosas.
Gravidez categoria C – Este medicamento não deve ser utilizado por mulheres grávidas sem
orientação médica. O produto não deve ser utilizado durante a amamentação.
Este medicamento é contra-indicado para pacientes menores de 18 anos de idade, uma vez que não
foram feitos estudos nesta faixa etária.

Página 1 de 7


AVICIS / modelo de bula
Não são conhecidas interações com outros medicamentos.
Informe ao médico o aparecimento de reações indesejáveis.
Informe ao médico se você estiver fazendo uso de algum outro medicamento.
Não use medicamento sem o conhecimento do seu médico; pode ser perigoso para sua saúde.

Como devo usar este medicamento ?
Avicis é uma solução alcoólica. O produto é incolor ou levemente amarelado.

Mantenha o frasco na posição vertical. Faça um giro de 90º no
aplicador no sentido anti-horário. O produto estará pronto para ser utilizado.
Segurar o frasco pela sua base e apoiar o aplicador diretamente
sobre a área afetada do couro cabeludo.

O medicamento sairá pelo aplicador através dos pequenos orifícios já
existentes em sua ponta. Não é necessário apertar o frasco.

Deslizar levemente o aplicador até que toda a área afetada do couro cabeludo esteja
ligeiramente umedecida com o produto.
Página 2 de 7


AVICIS / modelo de bula
Após o uso, fechar o aplicador girando 90º em sentido horário, para evitar a
saída do líquido.

EXCLUSIVAMENTE PARA USO TÓPICO NO COURO CABELUDO. NÃO DEVE SER
APLICADO EM OUTRAS ÁREAS DO CORPO. EVITE O CONTATO COM OS OLHOS E
MUCOSAS.
Aplique o produto no couro cabeludo 1 vez por dia, de preferência à noite, usando o aplicador em
movimentos leves, durante o tempo suficiente para umedecer a área afetada. Utilize a ponta dos dedos
para massagear o produto no couro cabeludo. Lavar as mãos após o uso do produto.
Se for aplicado logo após o banho, recomenda-se secar bem o cabelo com uma toalha antes da
aplicação.
Se você esquecer uma aplicação, aplique AVICIS normalmente no dia seguinte, não sendo necessária
uma aplicação extra.
A melhora na queda dos cabelos não deve ser esperada antes de pelo menos 1 mês de tratamento.
Se você parar de aplicar o AVICIS, provavelmente o seu cabelo voltará a cair. Para obter o benefício
máximo no tratamento com AVICIS recomenda-se seguir rigorosamente o tempo de tratamento
prescrito pelo médico.
Para continuar o tratamento por mais de 1 ano você deve consultar novamente seu médico.
Siga a orientação do seu médico, respeitando sempre os horários, as doses e a duração do tratamento.
Quando ocorrer melhora da alopecia, a freqüência poderá ser diminuída para 1 aplicação a cada 2 ou 3
dias, porém esta redução deverá ser determinada pelo médico.
Não interrompa o tratamento sem o conhecimento do seu médico.
Não use o medicamento com o prazo de validade vencido.
Antes de usar, observe o aspecto do medicamento.

Quais os males que este medicamento pode causar?
Devido à presença de álcool na fórmula, podem ocorrer reações locais passageiras, tais como
queimação, coceira ou avermelhamento do couro cabeludo após a aplicação do produto.


O que fazer se alguém usar uma grande quantidade deste medicamento de uma só vez?
Use o produto conforme recomendação do seu médico. A aplicação do produto em excesso não fará
com que sejam obtidos resultados melhores ou mais rápidos e poderão ocorrer reações locais, tais
como queimação, coceira ou avermelhamento do couro cabeludo. Se as reações locais forem muito
intensas, interrompa o uso por 1-2 dias e procure orientação médica.


Página 3 de 7


AVICIS / modelo de bula
Onde e como devo guardar este medicamento?
O produto deve ser mantido em temperatura ambiente (entre 15ºCe 30ºC).
Todo medicamento deve ser mantido fora do alcance das crianças.


INFORMAÇÕES TÉCNICAS AOS PROFISSIONAIS DA SAÚDE

FARMACOLOGIA CLÍNICA E MECANISMO DE AÇÃO
O ingrediente ativo do produto é o alfaestradiol, um estereoisômero do hormônio sexual 17–
estradiol. Ao contrário do 17–estradiol, o alfaestradiol apresenta baixa afinidade com os receptores
de estrógeno (0,8%).
O alfaestradiol acelera a atividade proliferativa das células matrizes capilares humanas in vitro. Além
disso, antagoniza o efeito inibitório da testosterona e diidrotestosterona sobre os folículos capilares
anágenos humanos in vitro. O mecanismo de ação se dá, provavelmente, através da inibição da
testosterona 5–redutase na pele.


Farmacocinética
A administração tópica do produto produz concentrações eficazes do alfaestradiol na pele. Após a
administração oral, o alfaestradiol é rapidamente metabolizado no organismo, sendo encontrado em
pequena proporção (aproximadamente 3%) na urina, na fração estrona-estradiol-estriol, sendo
excretado principalmente sob a forma de glucuronide.


Resultados de eficácia
Estudos clínicos controlados com placebo mostraram um aumento na proporção de fios anágenos na
região frontoparietal, não mostrando diferença em pacientes de ambos os sexos. O produto mostrou-se
eficaz em aproximadamente 85% dos pacientes.


INDICAÇÕES
AVICIS (alfaestradiol) solução capilar é indicado nos casos de diminuição da fase anágena no ciclo de
desenvolvimento capilar na alopecia androgenética leve a moderada, em homens e mulheres (queda de
cabelos por fatores hormonais).

CONTRA-INDICAÇÕES
Hipersensibilidade a qualquer dos componentes da preparação.

MODO DE USAR

Avicis é uma solução alcoólica. O produto é incolor ou levemente amarelado.
Página 4 de 7


AVICIS / modelo de bula

Mantenha o frasco na posição vertical. Faça um giro de 90º no
aplicador no sentido anti-horário. O produto estará pronto para ser utilizado.
Segurar o frasco pela sua base e apoiar o aplicador diretamente
sobre a área afetada do couro cabeludo.

O medicamento sairá pelo aplicador através dos pequenos orifícios já
existentes em sua ponta. Não é necessário apertar o frasco.

Deslizar levemente o aplicador até que toda a área afetada do couro cabeludo esteja
ligeiramente umedecida com o produto.
Após o uso, fechar o aplicador girando 90º em sentido horário, para evitar a
saída do líquido.


EXCLUSIVAMENTE PARA USO TÓPICO NO COURO CABELUDO. NÃO DEVE SER
APLICADO EM OUTRAS ÁREAS DO CORPO. EVITE O CONTATO COM OS OLHOS E
MUCOSAS.
Aplique o produto no couro cabeludo 1 vez por dia, de preferência à noite, usando o aplicador em
movimentos leves, durante o tempo suficiente para umedecer a área afetada. Utilize a ponta dos dedos
para massagear o produto no couro cabeludo. Lavar as mãos após o uso do produto.
Se for aplicado logo após o banho, recomenda-se secar bem o cabelo com uma toalha antes da
aplicação.
Página 5 de 7


AVICIS / modelo de bula
Se você esquecer uma aplicação, aplique AVICIS normalmente no dia seguinte, não sendo necessária
uma aplicação extra.
A melhora na queda dos cabelos não deve ser esperada antes de pelo menos 1 mês de tratamento.
Quando ocorrer melhora da alopecia, a freqüência poderá ser diminuída para 1 aplicação a cada 2 ou 3
dias, porém esta redução deve ser determinada pelo médico.
Se você parar de aplicar o AVICIS, provavelmente o seu cabelo voltará a cair. Para obter o benefício
máximo no tratamento com AVICIS recomenda-se seguir rigorosamente o tempo de tratamento
prescrito pelo médico.
A continuação do tratamento por mais de 1 ano deve ser supervisionada pelo médico.

ADVERTÊNCIAS
Gravidez categoria C – Este medicamento não deve ser utilizado por mulheres grávidas sem orientação
médica. Não existem dados referentes a animais ou seres humanos quanto ao uso do alfaestradiol
durante a gravidez e amamentação.

USO EM IDOSOS, CRIANÇAS E OUTROS GRUPOS DE RISCO
Não foram realizados estudos em pacientes com menos de 18 anos de idade.

REAÇÕES ADVERSAS
Devido à natureza alcoólica da solução, podem ocorrer reações locais passageiras, tais como
queimação, coceira ou avermelhamento do couro cabeludo após a aplicação do produto.

SUPERDOSE
AVICIS (alfaestradiol) solução capilar deve ser usado somente para aplicação tópica no couro
cabeludo. A aplicação do produto em excesso não fará com que sejam obtidos resultados melhores ou
mais rápidos e os efeitos indesejáveis descritos acima poderão aumentar ou intensificar-se.

ARMAZENAGEM
O produto deve ser mantido em temperatura ambiente (entre 15ºC e 30ºC).

MS-1.2916.0046.001-2
Farm. Resp.: Celso Mendes Alves ­ CRF-SP nº 23.479
Fabricado por
Laboratoires Galderma
Zone Industrielle de Montdésir
74540 Alby-sur-Chéran
França

Importado e distribuído por
GALDERMA BRASIL LTDA.
Rodovia SP-101 Km 9
Condomínio Tech Town
13186-904 – Hortolândia ­ SP
Página 6 de 7


AVICIS / modelo de bula
CNPJ 00.317.372/0004-99

Atendimento ao Consumidor
0800-0155552
sac@galderma.com

Venda sob prescrição médica

Lote, fabricação e validade : vide cartucho

Rev05
Página 7 de 7


Mais Bulas de Medicamentos


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    {Hi|Hello}, i think that i saw you visited my {blog|weblog|website|web site|site} {so|thus}
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